Online Emotional Regulation Group Treatment

October 1, 2015 updated by: Icahn School of Medicine at Mount Sinai

Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)

This study will examine the feasibility of online delivery of emotional regulation training to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online in group modality. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods. Treatment satisfaction and participant subjective experience will also be assessed.

Study Overview

Detailed Description

This study will examine the feasibility of online delivery of emotional regulation training to individuals with Traumatic Brain Injury who also have emotional dysregulation. 80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online via a group meeting software. Study participation will last 28 weeks: 4 weeks of baseline, 12 weeks of treatment (24 sessions) and 12 weeks of follow-up. Assessments will be conducted at each of four timepoints: T1 (baseline), T2 (pre-treatment assessment), T3 (end-of-treatment assessment) and T4 (follow-up assessment). In addition, a subset of the measures will be administered bi-weekly for the duration of the study. Assessments will consist of a variety of measures designed to measure executive functioning, problem solving skills, and quality of life. All assessments will be completed online, using a web-based data collection. Attendance and treatment compliance will be tracked, and outcomes will be monitored using online data collection methods. Treatment satisfaction and participant subjective experience (including technical difficulties that make access to web-delivered treatment impossible) will also be assessed.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10029
        • The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented TBI of any severity and being at least 6 months post injury
  • Presence of executive dysfunction, manifested as self-reported difficulties with emotional and behavioral self-regulation, operationalized as endorsement of 25% or more of the symptoms on the Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004).
  • Currently aged 18 or older
  • English speaking
  • At least low average intellectual functioning, operationalized as a minimum Verbal IQ score of 80 on the Wechsler Abbreviated Scale of Intelligence
  • Ownership of and relative facility with use of a computer, webcam, and microphone
  • Access to a broadband internet connection at sufficiently high speed to allow videoconference

Exclusion Criteria:

  • DSM-IV-TR diagnosis of alcohol or substance abuse within past 6 months
  • DSM-IV-TR of psychosis within past 6 months
  • High suicidality, operationalized as a score of 17 or higher on the Mini International Neuropsychiatric Interview (M.I.N.I., Sheehan et al., 2008)

Participation in this study will not preclude participation in other treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online Emotional Regulation Treatment
Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
Emotional Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation. EmReg combines didactic and experiential training, and emphasizes skill acquisition and generalization through examination of incidents of emotional dysregulation in one's life and completion of homework assignments. The treatment is divided into two phases: knowledge provision and practice facilitation. During the knowledge provision phase participants are introduced to the objectives and the main concepts of the treatment, to increase their familiarity with the terminology, and to the emotional regulation skills they acquire during the practice facilitation phase. During the practice facilitation phase participants receive training in emotional regulation skills, which they practice in-session with the guidance of the therapist and feedback from the group, as well as out-of-session as homework assignments.
Other Names:
  • Emotional Regulation Training (EmReg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulties in Emotion Regulation Scale(DERS)
Time Frame: up to 28 weeks
36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies
up to 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)
Time Frame: up to 28 weeks
32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI
up to 28 weeks
Problem Solving Inventory
Time Frame: up to 28 weeks
35-item self-report questionnaire assessing problem solving capability
up to 28 weeks
Social Problem Solving Inventory-Revised: Short Form
Time Frame: up to 28 weeks
25-item self-report questionnaire assessing problem solving in everyday living
up to 28 weeks
Positive Affect Negative Affect Scale
Time Frame: up to 28 weeks
20-item self-report measure of positive and negative affect within a specified time frame
up to 28 weeks
Satisfaction with Life Scale
Time Frame: T1 (baseline)
5- item measure of global satisfaction with life
T1 (baseline)
Satisfaction with Life Scale
Time Frame: T2 (week 4)
5- item measure of global satisfaction with life
T2 (week 4)
Satisfaction with Life Scale
Time Frame: T3 (week 16)
5- item measure of global satisfaction with life
T3 (week 16)
Satisfaction with Life Scale
Time Frame: T4 (week 28)
5- item measure of global satisfaction with life
T4 (week 28)
Satisfaction with Therapy and Therapist Scale
Time Frame: T3 (week 16)
12-item scale that assesses satisfaction with treatment and therapist
T3 (week 16)
Satisfaction with Therapy and Therapist Scale
Time Frame: T4 (week 28)
12-item scale that assesses satisfaction with treatment and therapist
T4 (week 28)
Treatment Compliance
Time Frame: up to 28 weeks
therapist's ratings of participant on each of the following areas at each session: attendance, participation, homework completion, skill acquisition, skill generalization, ease of use of technology, and interpersonal behavior
up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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